Syringe set

ABSTRACT

A syringe holder which is capable of holding a plurality of types of syringes used for expanding a balloon catheter so as to be capable of being detached and attached is proposed. Preferably, a clearance is provided between the syringe holder and the syringe, so that gas can come into sufficient contact therewith during sterilizing treatment. The syringe holder in this arrangement can be formed, for example, by forming a plurality of grooves which are similar to the shape of the syringe and slightly larger than the syringe on a sheet formed of resilient member. Preferably, the shape is devised to prevent dropping off of the syringe from the syringe holder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/493,192 filed Jul. 26, 2006, by Ryuji NAGAMATSU, entitled SYRINGEHOLDER FOR BALLOON CATHETER AND SYRINGE SET FOR BALLOON CATHETER, whichis a divisional of U.S. application Ser. No. 11/128,092 filed May 11,2005, by Ryuji NAGAMATSU, entitled SYRINGE HOLDER FOR BALLOON CATHETERAND SYRINGE SET FOR BALLOON CATHETER, which claims the benefit ofpriority from prior Japanese Patent Application No. 2004-143616, filedon May 13, 2004, the entire contents of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a technique to store and retain asyringe used for a balloon catheter. More specifically, the inventionrelates to a syringe holder and a syringe set with the syringe stored inthe syringe holder.

2. Description of the Related Art

A balloon catheter is an instrument for administering medical treatmentfor a living body. The balloon catheter includes a catheter to beinserted into a body, and is provided with a balloon at the distal endof the catheter. The balloon is formed by covering a tube on the outerperiphery of the catheter and fixing the both ends thereof. The catheteris formed with a lumen communicating with the inside of the balloon, andthe balloon can be inflated by sending air into the lumen (for example,see JP-A-2002-143311).

In the related art, when using the balloon catheter in a luminalstructure, barium meal is used for taking X-ray movie for control theamount of air to be supplied while observing the diameter of the balloonin many cases. In this case, the balloon can be observed clearly alongthe outline thereof at a portion pushed against an inner wall of theluminal structure since the barium meal is moved away at this portion.However, at a portion of the balloon which is hidden by the barium meal,the outline thereof cannot be observed clearly, and hence the precisesize of the balloon cannot be obtained.

To cope with this problem, there is a technique for providing aplurality of syringes having different capacities in advance so that thesize of the balloon can be controlled without using X-rays, and using asyringe of a desired capacity in connection with the balloon catheterfor controlling the size of the balloon. In this case, the plurality ofsyringes are prepared in a sterilized packages for the balloon catheterand a required syringe is taken out from the sterilized package for use.Alternatively, there is a case where a plurality of syringes are storedin a sterilized package and the sterilized package is stored in anothersterilized package for the balloon catheter.

However, in the case where the plurality of syringes are stored in thesterilized package, the syringes are often scattered in the sterilizedpackage during transportation, and hence it is difficult to take arequired syringe. When the sterilized package in which only the syringesare stored is stored in another sterilized package, since the syringesare packed twice, it takes time for taking the syringe out. In view ofefficiency of manipulation, it is preferable that an operator can selecta syringe optimal for manipulation easily out of the plurality ofsyringes that are similar in appearance.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a syringe holder for a balloon catheterwhich can hold a plurality of syringes so as to be capable of beingattached and detached. In this arrangement, the plurality of syringescan be treated together as a single unit. Since the syringes are held soas to be capable of being attached and detached, an operator can takeonly a required syringe when in use.

Preferably, a holding part for holding the syringe is formed with anallowance with respect to the contour of the syringe, and an innersurface includes at least one protrusion.

In this arrangement, the syringe and the syringe holder do not come intotight-contact with each other and there exists a clearance therebetween.Since the syringe is supported by the protrusion, the contact areabetween the syringe and the holding part is reduced. It has an advantagein that gas can intrude easily into the syringe during sterilizingtreatment. As a method of defining the clearance, a non-circularcross-section may be employed for the holding part.

Preferably, the sizes of the plurality of holding parts are notidentical, so as to be capable of accommodating the syringes havingdifferent outer diameters.

In this arrangement, the plurality of syringes having different sizescan be accommodated. This is an advantageous characteristic for a casein which the amount of expansion of the balloon is controlled by thesize of the syringe which supplies fluid. Since the operator can selecta suitable syringe out of the plurality of syringes having differentsizes by intuition, the working efficiency is improved.

Preferably, the holding part includes a flat portion for constrainingrotation of the syringe by coming into abutment with a flange of thesyringe.

In this arrangement, the rotation of the syringe stored in the syringeholder can be constrained. Therefore, when there are indications on thesurfaces of the syringes, a uniform orientation of the indications isachieved, and hence visibility is improved.

Preferably, the holding part is formed with an opening for allowing adistal portion of the syringe on the side of a connecting portionthereof to be projected, which is to be connected to the ballooncatheter.

In this arrangement, the syringe can be separated from the syringeholder easily by griping the projected portion.

The holding part may be, for example, a storage groove, which is agroove having an opening to which the syringe can be inserted. When theholding part is the groove, the syringe can be inserted easily from theopening. When the storage groove is employed, a projection forpreventing the stored syringe from coming off may be provided at anupper portion thereof. When the syringe holder has resiliency, thesyringe can be inserted easily by widening the opening by resilientdeformation.

By adapting the shape of the storage groove to the shape of the syringe,the operator can know the storing position or the storing direction ofthe syringe with a glance. More specifically, the storage grooveincludes at least a cylinder storage groove for storing the cylinder ofthe syringe, a flange storage groove for storing the flange of thesyringe, and a plunger storage groove for storing a plunger of thesyringe so as to communicate with each other.

It is preferable to provide a device for preventing the syringe or theplunger of the syringe from dropping off. For example, the size of thecylinder storage groove is determined to be smaller than that of theflange of the syringe, so that the cylinder of the syringe is preventedfrom moving and dropping off in the axial direction. The plunger storagegroove is closed at one end surface so that the plunger of the syringeis prevented from coming off and dropping off from the cylinder.

Preferably, the storage groove prevents the axial rotation of thesyringe. It is because the syringe is stabilized, and the position ofindication formed on the syringe is also kept constant.

The invention may also be understood as a syringe set combining thesyringe holder and the syringe stored in the syringe holder.

According to the invention, the plurality of syringes can be stored inthe syringe holder. Therefore, when the syringe holder is stored in thesterilized package, the syringes are prevented from being scattered inthe sterilized package, and hence can be treated as a single unit.Therefore, handling in use or selection of a syringe is facilitated.Therefore, the manipulation can be facilitated, and the manipulationtime can be reduced.

When the allowance is provided in the storage groove of the syringeholder, since a clearance is defined between the syringe holder and thesyringe, sterilization by gas such as ethylene oxide gas can easily beachieved. In addition, by reducing the contact area between the syringeand the syringe holder by the protrusion, the clearance between thesyringe and the syringe holder can be sterilized further reliably.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

These and other features, aspects, and advantages of the apparatus andmethods of the present invention will become better understood withregard to the following description, appended claims, and accompanyingdrawings where:

FIG. 1 is a top view of a syringe set according to an embodiment of theinvention;

FIG. 2 is a drawing viewed in the direction indicated by an arrow A inFIG. 1;

FIG. 3 is a drawing showing a structure of a syringe;

FIG. 4 is a cross-section of FIG. 1 showing a case in which the syringesare not mounted;

FIG. 5 is a cross-section of FIG. 1 showing a case in which the syringesare not mounted.

FIG. 6 is a cross-sectional view showing an example of a ballooncatheter;

FIG. 7 is a cross-sectional view showing the distal portion of theballoon catheter;

FIG. 8 is a top view of a syringe holder;

FIG. 9 is a cross-section of FIG. 8;

FIG. 10 is a cross-section of FIG. 8:

FIG. 11 is a drawing showing a cylinder storage groove;

FIG. 12 is a drawing showing the cylinder storage groove;

FIG. 13 is a top view of the syringe set; and

FIG. 14 is a cross-section of FIG. 13.

DETAILED DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described below withreference to the accompanying drawings.

FIG. 1 and FIG. 2 show a syringe set 1 having three syringes 2, 3 and 4with different capacities stored in a syringe holder 5.

The syringes 2, 3 and 4 are shown in FIG. 3A to FIG. 3C. As shown inFIG. 3C, the syringe 2 includes a cylinder 6 as an outer cylindricalmember and a plunger (push rod) 7 to be slidably inserted into thecylinder 6.

The cylinder 6 includes a distal portion 6 a having smaller diameter atthe distal end thereof, and a connecting portion 8 extends therefromalong the axial line. The connecting portion 8 is formed with an outletport 9 for communicating the interior of the cylinder 6 with the outsidealong the axial line thereof. The outlet port 9 is for introducing airto a balloon catheter, described later. The connecting portion 8 is alsoprovided with a cylindrical portion 10 so as to cover the outlet port 9,and the cylindrical portion 10 is formed with an inner thread 10 a. Aproximal portion 6 b of the cylinder 6 is formed with an insertion port11 a so as to allow the plunger 7 to be inserted therein. The proximalportion 6 b of the cylinder 6 is formed also with a flange 12 a extendedin the direction substantially orthogonal to the axial line of thecylinder 6 and in the radial direction of the cylinder 6. The cylinder 6has a substantially uniform inner diameter to the insertion port 11 a atthe proximal portion 6 b except for the distal portion 6 a with reduceddiameter. The inner peripheral surface near the insertion port 11 a isformed with a projection (not shown) for preventing the plunger 7 fromcoming off.

The cylinder 6 is formed with a scale 13 a on the outer peripheralsurface along the axial line thereof. The scale 13 a shows a capacity ofa space formed in the cylinder with reference to the side of the distalportion 6 a. However, the scale is not limited thereto, and may be thatindicating the outer diameter of the expended balloon when a seal member19 a, described later, is moved from the position on the scale to thedistal end.

The cylinder 6 is formed with a hole 14 so as to align with the scale 13a. The hole 14 communicates between the inside and the outside of thecylinder 6, and is formed at a position where a predetermined capacity(first capacity) is defined in the cylinder 6. The first capacitycorresponds, for example, to the amount of air which expands the balloonto 8.5 mm in diameter.

The cylinder 6 is also formed with a hole 15 at a position shifted fromthe hole 14 by about ¼ turn in the circumferential direction (about 90°in angle). The hole 15 communicates between the inside and the outsideof the cylinder 6, and has substantially the same size as the hole 14.

The plunger 7 has a main body 18 a formed by two plate strips 17 aintersected into a cross-shape. The main body 18 a has a size which canbe inserted into the cylinder 6, and is attached with the seal member 19a at the distal end thereof. The seal member 19 a has a sealing surface20 a which is kept in sliding contact with the inner peripheral surfaceof the cylinder 6, so as to establish air-tightness between the innerperipheral surface of the cylinder 6 and the seal member 19 a. The mainbody 18 a is provided with a disk-shaped pressing portion 21 at theproximal end thereof.

As shown in FIG. 3B, the syringe 3 includes a cylinder 22 which islarger in inner diameter and in outer diameter than the syringe 2, and aplunger 23 to be slidably inserted into the cylinder 22, and has thesame structure as the syringe 2. In other words, the cylinder 22 isprovided with the connecting portion 8 at a distal portion 22 a, and isformed with an insertion port 11 b at a proximal portion 22 b. Theproximal portion 22 b is provided with a flange 12 b extended therefrom.The cylinder 22 is formed with two holes 24, 25 at a positioncorresponding, for example, to the amount of air (second capacity) whichexpands the balloon to 11.5 mm in diameter with reference to the distalportion 22 a. The hole 24 is formed on a scale 13 b, and the hole 25 isformed at a position shifted by about 90° in the circumferentialdirection from the hole 24. The plunger 23 has a size corresponding tothe cylinder 22, and a main body 18 b having plate strips 17 bintersected to each other is provided with a seal member 19 b at thedistal end thereof. The seal member 19 b is formed with a sealingsurface 20 b on the outer peripheral surface thereof which is kept insliding contact with the inner peripheral surface of the cylinder 22 soas to establish air-tightness.

As shown in FIG. 3A, the syringe 4 includes a cylinder 26 larger thanthe syringe 3 in inner diameter and outer diameter, and a plunger 27 tobe slidably inserted in the cylinder 26, and has the same structure asthe syringes 2 and 3. In other words, the cylinder 26 is provided withthe connecting portion 8 at a distal portion 26 a thereof, and aninsertion port 11 c at the proximal portion 26 b. The cylinder 26 isalso provided with a flange 12 c at a proximal portion 26 b thereof. Thecylinder 26 is formed with two holes 28, 29 at positions corresponding,for example, to the amount of air (third capacity) which can expand theballoon to 15 mm in diameter with reference to the distal portion 26 a.The hole 28 is provided on a scale 13 c, and the hole 29 is formed at aposition shifted by about 90° from the hole 28 in the circumferentialdirection. The plunger 27 has a size corresponding to the cylinder 26and a main body 18 c having plate strips 17 c intersected to each otheris provided with a seal member 19 c at the distal end thereof. The sealmember 19 c has a sealing surface 20 c on the outer peripheral surfacethereof which is kept in sliding contact with the inner peripheralsurface of cylinder 26 so as to establish air-tightness therebetween.

The syringe set 1 including the aforementioned syringes 2, 3 and 4 andthe syringe holder 5 for storing these syringes is shown in FIG. 1 andFIG. 2. The syringe holder 5 has a main body 31 formed of a sheet ofsubstantially rectangular in plan view having a flange 30 along theperipheral edge thereof, and the inner side of the flange is protrudedupward. The main body 31 is formed into a trapezoidal shape in sideview, in which the flange 30 corresponds to the bottom side. The shorterside of the main body 31 is shorter than the length of the syringes 2, 3and 4. The main body 31 includes a side surface 31 a and a side surface31 b located on the side opposite from the side surface 31 a.

The main body 31 is further formed with three recessed holding parts 32,33 and 34 arranged along the longer side of the main body 31 in parallelwith each other. The holding part 32 is used for storing the syringe 2having the smallest capacity, the holding part 33 is used for storingthe syringe 3, and the holding part 34 is used for storing the syringe 4having the largest capacity.

As shown in FIG. 1, the holding part 32 includes a storage grooveopening on the upper side, and the storage groove is partitioned into acylinder storage groove 35 a, a flange storage groove 36 a, and aplunger storage groove 37 a from the side of the side surface 31 a.These grooves 35 a, 36 a and 37 a communicate with each other, and themain body 31 is formed with an opening 32 a on the side surface 31 a andthe opposing side surface 31 b of the main body 31 is closed.

The cylinder storage groove 35 a has larger width and depth incomparison with the diameter of the cylinder 6 and, in addition, theedge of an upper opening 32 b of the cylinder storage groove 35 a isprotruded so as to reduce the width of the upper opening 32 b.

The flange storage groove 36 a continues to the cylinder storage groove35 a, and is larger than the cylinder storage groove 35 a in width. FIG.4 is a cross-sectional view taken along a cutting line (FIG. 4-FIG. 4)in FIG. 1, showing that no syringe is mounted. As shown in FIG. 4, aside wall of the flange storage groove 36 a has an inclination beingreduced in width toward the bottom, and the bottom has a form of asmooth depression. FIG. 5 shows a cross-sectional view taken along acutting line (FIG. 5-FIG. 5) in FIG. 1, showing that no syringe ismounted. As shown in FIG. 5, the depth of the flange storing groove 36 ais deeper than that of the cylinder storage groove 35 a, and a boundaryplane between the flange storage groove 36 a and the cylinder storagegroove 35 a is formed to have an inclination. In the same manner, aboundary plane between the flange storage groove 36 a and the plungerstorage groove 37 a is formed to have an inclination.

The depth of the plunger storage groove 37 a is almost the same as thatof the flange storage groove 36 a, and the radius of curvature of thebottom is smaller than that of the pressing portion 21 of the plunger 7.As shown in FIG. 4, the width of the plunger storage groove 37 a issmaller than that of the flange storage groove 36 a. The side surface 31b side of the plunger storage groove 37 a is closed by a closed surface38 a, and the closed surface 38 a is inclined so that the depth of theplunger storage groove 37 a is reduced toward the bottom (see FIG. 5).

As shown in FIG. 1 and FIG. 4, the storage groove of the holding part 33is partitioned into a cylinder storage groove 35 b, a flange storagegroove 36 b, and a plunger storage groove 37 b, and an opening 33 a isformed on the side surface 31 a side. The width and the depth of thecylinder storage groove 35 b are larger than those of the cylinderstorage groove 35 a. The width and the depth of the flange storagegroove 36 b are larger than those of the cylinder storage groove 35 b,and the bottom is formed into a recessed shape. The depth of the plungerstorage groove 37 b is about the same as that of the flange storagegroove 36 b, and the width thereof is smaller than that of the flangestorage groove 36 b. The closed surface 38 b on the side of the sidesurface 31 b of the plunger storage groove 37 b, a boundary planebetween the plunger storage groove 37 b and the flange storage groove 36b, and a boundary plane between the flange storage groove 36 b and thecylinder storage groove 35 b are inclined as in the same manner as thesurfaces corresponding to the holding part 32.

The holding part 34 has the same structure as the holding part 33 exceptthat the width and the depth are different. In other words, the holdingpart 34 is provided with an opening 34 a on the side surface 31 a side,and is partitioned into a cylinder storage groove 35 c, a flange storagegroove 36 c and a plunger storage groove 37 c. The width and the depthof the flange storage groove 36 c are larger than those of the cylinderstorage groove 35 c, and the bottom is formed into a recessed shape. Thedepth of the plunger storage groove 37 c is almost the same as that ofthe flange storage groove 36 c, and the width thereof is smaller thanthat of the flange storage groove 36 c. The closed surface 38 c on theside of the side surface 31 b of the plunger storage groove 37 c, aboundary plane between the plunger storage groove 37 c and the flangestorage groove 36 c, and a boundary plane between the flange storagegroove 36 c and the cylinder storage groove 35 c are inclined as in thesame manner as the surfaces corresponding to the holding parts 32, 33.

The syringe holder 5 as described above is formed by vacuum-molding asheet material having flexibility, such as polypropylene orpolyethylene, polystyrene or polyethylene terephthalate, polycarbonateor ABS (acetonitrile butadiene styrene), metacrylate resin.

Referring now to FIG. 6 and FIG. 7, an example of a balloon catheter tobe stored in the sterilized package together with the syringe set 1 willbe described.

FIG. 6 shows a balloon catheter 40 and an operating portion 49. Theballoon catheter 40 includes a flexible catheter (sheath) 41 to beinserted into the luminal structure, and a balloon 42 is mounted to thedistal end of the catheter 41. The balloon 42 is a tube formed, forexample, of natural rubber latex, and the distal portion of the catheter41 is inserted through the tube, and then both ends 42 a thereof arefixed by being bound by strings 43 (FIG. 7) and applied with adhesiveagent. When air is supplied to the balloon 42, an intermediate portion42 b which is not fixed can be expanded, as shown in FIG. 7.

An expansion lumen 44 is formed in the catheter 41. The expansion lumen44 is closed at the distal portion thereof, and is formed with a sidehole 45 in communication with the intermediate portion 42 b of theballoon 42. The catheter 41 is formed therein with a guide lumen 46 anda liquid-delivery lumen 47 arranged in substantially parallel to eachother. A guide wire or a stylet is inserted through the guide lumen 46when inserting the distal portion of the catheter 41 into the luminalstructure. The liquid-delivery lumen 47 is used for injecting the bariummeal into the luminal structure. The distal portion of theliquid-delivery lumen 47 is closed and is provided with a side hole 48for communicating with the outside. It is also possible to inject thebarium meal using the guide lumen 46 instead of forming theliquid-delivery lumen 47.

The catheter 41 is provided with the operating portion 49 at theproximal portion thereof. The operating portion 49 includes a blanchmember 50 connected to the catheter 41, an expansion shaft 51 and aguide shaft 52 are extended from the branch member 50. The expansionshaft 51 is formed therein with a lumen which communicates with theexpansion lumen 44, and the expansion shaft 51 is provided with a pipesleeve 53 of a lure-shape at the proximal portion thereof. One of thesyringes 2, 3 and 4 is connected to the pipe sleeve 53 via a valve 54. Apipe sleeve 55 is mounted to the proximal portion of the guide shaft 52.The pipe sleeve 55 is provided with two inlets 56, 57. The inlet 56 isin communication with the guide lumen 46, and a guide wire is insertedtherethrough to enhance rigidity of the catheter 41 and hence thepushability can be improved. The inlet 57 is communicated with theliquid-delivery lumen 47, so that a syringe for barium meal in whichbarium meal is stored can be connected thereto.

Subsequently, the operation of the syringe set 1 and the syringe holder5 will be described.

The syringe 2 is stored in the holding part 32 of the syringe holder 5.More specifically, the syringe 2 is pushed in the syringe holder 5 fromthe upper opening 32 b so that the flange 12 a of the cylinder 6 isstored in the flange storage groove 36 a. The cylinder 6 is inserted soas to open the edge of the upper opening 32 b of the cylinder storagegroove 35 a. At this time, since the length of the cylinder storagegroove 35 a is shorter than the cylinder 6, the distal portion 6 a sideof the cylinder 6 projects from the side surface 31 a of the syringeholder 5. The flange 12 a of the cylinder 6 is stored in the flangestorage groove 36 a, and the pressing portion 21 is stored in theplunger storage groove 37 a.

The width and the depth of the cylinder storage groove 35 a are largerthan those of the cylinder 6 of the syringe 2, so that an allowance isformed with respect to the syringe 2. Therefore, high-pressure steam inthe autoclave for sterilizing treatment or ethylene oxide gas can easilypermeate therein. Since the flange 12 a of the syringe 2 and theboundary plane between the flange storage groove 36 a and the cylinderstorage groove 35 a come into abutment with each other, the syringe 2 isprevented from dropping off from the side of the opening 32 a. Since theplunger storage groove 37 a side is closed by the closed surface 38 a,the syringe 2 does not come off from this side.

In the same manner, the syringe 3 is inserted from the upper opening 33b into the holding part 33 so as to be held thereby, and the syringe 4is inserted from the upper opening 34 b into the holding part 34 so asto be held thereby.

The syringe set 1 having the respective syringes 2, 3 and 4 stored inthe syringe holder 5 is stored in a sterilized package (not shown).After having stored additional members such as the balloon catheter 40shown in FIG. 6, the sterilized package is sealed, and subjected tosterilizing treatment. The sterilizing treatment includes high-pressuresteam sterilization by the autoclave, or sterilization by ethylene oxidegas.

When inserting the balloon catheter 40 into the luminal structure andexpanding the balloon 42, the inner thread 10 a of the connectingportion 8 of a selected one of the three syringes 2, 3 and 4 is screwedonto the valve 54 to connect the same. When removing the syringe 2, 3 or4 from the syringe holder 5, the operator holds the distal portion ofthe syringe 2, 3 or 4 exposed from the syringe holder 5 and pulls outthe same. For example, when connecting the syringe 2 from the ballooncatheter 40, the plunger 7 is pulled back toward the proximal portion 2b side of the syringe 2 in advance.

When the syringe 2 is connected, the operator holds the flange 12 a ofthe cylinder 6 and the pressing portion 21 of the plunger 7 betweenhis/her fingers of one hand, and holds the cylinder 6 with the otherhand and pushes the plunger 7 slowly toward the distal portion 6 a ofthe cylinder 6.

No air is supplied to the balloon 42 (see FIG. 3) until the sealingsurface 20 a of the seal member 19 a of the plunger 7 reaches the holes14 and 16. In other words, no air is supplied to the balloon 42 becausealthough the capacity defined by the seal member 19 a and the interiorof the cylinder 6 is reduced when the plunger 7 is pushed therein, aircorresponding to the reduced capacity is released through the two holes14 and 15 which have less resistance.

When the operator further pushes the plunger and hence the seal member19 a moves toward the distal portion 6 a beyond the position where theholes 14 and 15 are formed, air starts to be supplied to the balloon 42.In other words, since the seal member 19 a is positioned on the side ofthe distal portion 6 a with respect to the holes 14 and 15, the air inthe space in the cylinder 6 is not released any longer from the holes 14and 15, and hence the air corresponding to the reduced capacity is sentto the balloon catheter 40 from the outlet port 9. The air is suppliedto the balloon 42 through the expansion lumen 44 shown in FIG. 6.Consequently, the balloon 42 expands according to the reduced amount ofthe capacity in the cylinder 6 (see FIG. 7).

In other words, when the plunger 7 is pushed into the distal portion 6a, the amount of air corresponding to the first capacity is sent intothe syringe 2, and hence the balloon 42 is expanded to an extentcorresponding to the first capacity. When the syringe 3 is selected, theamount of air corresponding to the second capacity is sent thereto, sothat the balloon 42 is expanded. When the syringe 4 is selected, theamount of air corresponding to the third capacity is sent thereto, andthe balloon 42 is expanded.

When pushing the plunger 7, 23 or 27, the operator may place his/herfingers on the outer periphery of the cylinder 6, 22 or 26. In thiscase, he/she may clog one of the holes 14, 24, or 28 and the holes 15,25 or 29 by his/her finger. However, in this embodiment, since the twoholes are provided, there is no possibility that the two holes 14 and15, 24 and 25, or 28 and 29 are clogged simultaneously, whereby theamount of air to be supplied to the balloon 42 can be reliably secured.In particular, since the two holes 14 and 15, 24 and 25, or 28 and 29are formed at the positions shifted about 90° in the circumferentialdirection, even though one of these holes 14, 24 or 28 is clogged whenthe operator places the cylinder 6, 22 or 26 between his/her fingers,the other hole 15, 25 or 29 is kept unclogged.

In this embodiment, since the plurality of syringes 2, 3 and 4 areprepared according to the size of the balloon 42 to be expanded, and thesyringes 2, 3 and 4 are stored in a line in the syringe holder 5, thesyringes 2, 3 and 4 are prevented from scattered while they are storedin the sterilized package or when taking out from the sterilized packagefor use, and hence usability is improved. Also, since the syringes arenot stored in the double sterilized packages as in the related art, therequired syringe 2, 3, or 4 can be taken out quickly, and hence the timefor manipulation can be reduced.

Since the distal portions of the syringes 2, 3 and 4 project from thesyringe holder 5, the syringes 2, 3 and 4 can be taken out easily fromthe syringe holder 5.

The syringes 2, 3 and 4 may not have holes 14, 15, 24, 25, 28 and 29.Since the capacities in the cylinders 6, 22 and 26 of the syringes 2, 3and 4 when the plungers 7, 23 and 27 are pulled back are different fromeach other, the balloon 42 can be expanded to different sizesrespectively by the syringes 2, 3 and 4 even though the holes are notformed.

Subsequently, referring to the drawings, a second embodiment of theinvention will be described. The same components as the first embodimentare represented by the same reference numerals. Description overlappedwith the first embodiment will be omitted.

As shown in FIG. 8, a syringe holder 60 is provided with three recessedholding parts 61, 62 and 63 along the longer side thereof.

The respective holding parts 61, 62 and 63 extend from openings 61 a, 62a and 63 a which are formed on the side surface 31 a of the main body 31and then extended towards the side surface 31 b. These holding parts 61,62 and 63 differ from the first embodiment in the forms of cylinderstorage grooves 64 a, 64 b and 64 c.

As shown in FIG. 8 and FIG. 9, the cylinder storage groove 64 a isformed substantially into a U-shape, and the width and the depth thereofare formed to be larger than those of the cylinder 6 in diameter. Abottom portion of the cylinder storage groove 64 a is formed with threeprotrusions 65 at regular intervals. The protrusions 65 have shape andsize which come into point contact with the cylinder 6, and the heightthereof is such that the upper surface of the cylinder 6 does notproject from an upper opening 61 b of the cylinder storage groove 64 ain a state in which the cylinder 6 is placed on the protrusion 65.

Furthermore, as shown in FIG. 9, the side walls near the upper opening61 b of the cylinder storage groove 64 a are formed with protrusions 66so as to protrude at opposed positions for reducing the width of thecylinder storage groove 64 a. The positions where the protrusions 66 areformed are such that a predetermined clearance is formed with respect tothe upper surface of the cylinder 6 in a state in which the cylinder 6is placed on the protrusion 65. The protrusions 66 are reduced in widthfrom the proximal portions continuing from the side walls of thecylinder storage groove 64 a toward the distal portions, and the distalportions are formed into a flat surface extending in parallel with thevertical direction. As shown in FIG. 10, the inclination of a lowersurface 66 a of the protrusion 66, which is a side surface extendingfrom the proximal portion to the distal portion, exposing itself to thebottom side of the cylinder storage groove 64 a is less steep than anupper surface 66 b. The protrusions 66 are disposed near the center ofthe main body 31 in the direction of the shorter side so as to oppose toeach other, and extend in the direction of the length of the cylinderstorage groove 64 a respectively.

As shown in FIG. 8 and FIG. 9, the cylinder storage groove 64 b of theholding part 62 is larger than the cylinder storage groove 64 a in widthand depth, and is formed with three protrusions 65 at the bottomthereof. The two each of protrusions 66 are formed near an upper opening62 b of the holding part 62 on the side walls of the cylinder storagegroove 64 b along the length of the cylinder storage groove 64 b atopposed positions.

The cylinder storage groove 64 c of the holding part 63 is larger thanthe cylinder storage groove 64 b in width and depth, and threeprotrusions 65 are provided at the bottom thereof. The two each ofprotrusions 66 are formed near an upper opening 63 b of the holding part63 on the side walls of the cylinder storage groove 64 c along thelength of the cylinder storage groove 64 c at opposed positions.

The operation of the syringe set will be described.

The syringe 2 is firstly stored in the holding part 61 of the syringeholder 60. When the syringe 2 is pushed into the holding part 61 fromthe upper opening 61 b side so that the flange 12 a of the cylinder 6 isstored in the flange storage groove 36 a, the cylinder 6 is insertedtherein so as to widen the distance between the protrusions 66, and isset in the cylinder storage groove 64 a. After the cylinder 6 haspassed, the protrusions 66 return to their original position.

In the stored state, the syringe 2 is supported mainly by theprotrusions 65 at the bottom of the cylinder storage groove 64 a. Thecylinder storage groove 64 a is larger than the syringe 2 so as to keepan allowance.

Likewise, the syringe 3 is stored in the holding part 62, and thesyringe 4 is stored in the holding part 63. In this state, therespective syringes 3 and 4 are mainly supported by the protrusions 65of the respective cylinder storage grooves 64 b and 64 c.

The syringe holder 60 in which the syringes 2, 3 and 4 are stored isplaced in the sterilized package, and is subjected to sterilizingtreatment together with the balloon catheter 40 and the like. At thistime, since there are sufficient allowances between the syringes 2, 3and 4 and the holding parts 61, 62 and 63, respectively, and the contactareas between the syringes 2, 3 and 4 and the holding parts 61, 62 and63 are kept at the minimum areas owing to the protrusions 65, 66, gascan easily run through. Furthermore, since the flange storage grooves 36a, 36 b and 36 c and the plunger storage grooves 37 a, 37 b and 37 c areformed into inclined surfaces or surfaces having the radius of curvaturedifferent from the syringes 2, 3 and 4 so as to form the clearances withrespect to the syringes 2, 3 and 4, gas can easily run through.Therefore, the syringes 2, 3 and 4 are reliably sterilized bysterilizing gas.

In this embodiment, since the holding parts 61, 62 and 63 are formed soas to secure the sufficient allowances with respect to the syringes 2, 3and 4, the clearances between the holding portions 61, 62, 63 and thesyringes 2, 3, 4 are secured, whereby the syringes 2, 3 and 4 can bereliably sterilized. In particular, since the contact areas with respectto the syringes 2, 3 and 4 are reduced by means of the protrusions 65and 66, sterilization of the syringes 2, 3 and 4 can be reliablyperformed.

Also, since the allowances are formed with respect to the syringes 2, 3and 4, and the distal ends of the respective syringes 2, 3 and 4 areexposed, the syringes 2, 3 and 4 can easily be taken out.

Subsequently, referring to the drawings, a third embodiment of theinvention will be described. The same components as the above-describedembodiments are represented by the same reference numerals. Descriptionoverlapped with the above-described embodiments will be omitted.

This embodiment relates to a modification of the holding part.

As shown in FIG. 11, holding parts 71, 72 and 73 of a syringe holder 70respectively have cylinder storage grooves 74 a, 74 b and 74 c beingsubstantially oval in cross-section.

The cylinder storage groove 74 a is configured in such a manner that theportion near an upper opening 71 b is protruded so as to be close toeach other, so that protrusions 75 a are formed, and the bottom side isformed into an oval shape. The number of contact portions between aninner wall of the cylinder storage groove 74 a and the cylinder 6 arethree positions at maximum including one on the bottom side and two onthe side of the protrusions 75 a. Each of them is subjected to linearcontact. Other portions of the syringe 2 are not in contact with theholding part 71 and clearances are formed. The cylinder storage groove74 b of the holding part 72 is larger than the cylinder storage groove74 a, is provided with protrusions 75 b near an upper opening 72 b, andis oval shape on the bottom side. The cylinder storage groove 74 c ofthe holding part 73 is larger than the cylinder storage groove 74 b, isprovided with protrusions 75 c near an upper opening 73 b, and is ovalshape on the bottom side.

They may be the cylinder storage grooves 81, 82 and 83 as shown in FIG.12.

The cylinder storage groove 81 is substantially formed into across-shape with reference to an upper opening 81 b. The cylinder 6 ismainly stored in a center portion of the cylinder storage groove 81, andclearances are defined with respect to the cylinder 6 by extendedportions 81 a extending in four directions from the center portion. Therespective corners which correspond to the proximal ends of the extendedportions 81 a come into linear contact with the cylinder 6 at fourpositions at the maximum.

The cylinder storage groove 82 substantially formed into a T-shape withreference to an upper opening 82 b. The width of the upper opening 82 bis smaller than the cylinder 22. The bottom side is increased in width,and this widened portion 82 a defines clearances with respect to thecylinder 22. The cylinder storage groove 82 is configured to come intolinear contact with the cylinder 22 at three portions at the maximumincluding the corners of the widened portion 82 a and the bottom.

The cylinder storage groove 83 is substantially formed into a triangularshape. In this case, the bottom corresponds to the bottom side of thetriangle, and an upper opening 83 b corresponds to one apex. The widthof the upper opening 83 b is smaller than the outer diameter of thecylinder 26, and the width of the portion near the bottom side is largerthan the cylinder 26. The cylinder storage groove 83 is configured todefine the clearance with respect to the cylinder 26, and contact withthe cylinder 26 at three portions at the maximum including the bottomand the inclined two side walls.

This syringe holder may be composed of the three cylinder storagegrooves of the same type selected from the cylinder storage grooves 81,82 and 83.

With the cylinder storage grooves 74 a, 74 b, 74 c, 81, 82 and 83, sincethe plurality of syringes 2, 3 and 4 can be held in line, usability isimproved, and time for manipulation may be reduced. Since the clearancesare defined between the syringes 2, 3 and 4 and the cylinder storagegrooves 74 a, 74 b, 74 c, 81, 82 and 83, gas can easily run throughduring gas sterilization, so that sufficient sterilization is achieved.

Referring to the drawings, a fourth embodiment of the invention will bedescribed. The same components as the above-described embodiments arerepresented by the same reference numerals. Description overlapped withthe above-described embodiments will be omitted.

FIG. 13 shows a state in which a syringe 92 is stored in a plurality ofrecessed holding parts 91 of a syringe holder 90.

The syringe 92 includes the cylinder 26, which is provided with anindication 93 on the outer peripheral surface at a position shifted fromthe direction of extension of the flange 12 c by about 90° in thecircumferential direction. In FIG. 13, the indication 93 includes astatement such as “For 15 mm balloon” or “15 mm”. This indication meansthat this syringe 92 can expand the balloon 42 to a size correspondingto the expanded diameter of 15 mm at the maximum.

The holding part 91 of the syringe holder 90 differs from the holdingpart 61 in the second embodiment in the structure of a flange storagegroove 94 c. As shown in FIG. 14, the flange storage groove 94 cincludes a flat portion 95 as the bottom. The flat portion 95 is formedat a depth so that the flange 12 c does not come into tight-contact withthe flat portion 95 but the flat portion 95 prevents the rotation of theflange 12 c when the syringe 92 is stored in the flange storage groove94 c. With this flat portion 95, movement in other directions, forexample, the movement in the direction of extension of the flange 12 c,or the movement in the direction of the depth of the flange storagegroove 94 c is allowed.

It is assumed that other holding parts, not shown, also have the flangestorage grooves having the flat portions and are adapted to store othersyringes so that the indications are visible.

Subsequently, the operation of the syringe holder 90 will be described.

The syringe 92 is inserted to the holding part 91 of the syringe holder90 so that the indication 93 is faced upward. At this time, theorientation of the flange 12 c of the syringe 92 is constrained by theflat portion 95 of the flange storage groove 94 c, and the flange 12 cis kept substantially in the horizontal direction. The indication 93 ofthe syringe 92 can always be viewed from above.

When the operator wants to expand the balloon 42 to a size correspondingto 15 mm in diameter, the operator checks the respective indications 93and selects the syringe 92 with the corresponding indication. Afterhaving held the distal portion of the syringe 92 and taken it out fromthe syringe holder 90, the plunger 7 is pulled back to the proximalportion 26 b and connected to the balloon catheter 40. When air is sentto the balloon 42 by the syringe 92, the balloon 42 is expanded to asize corresponding to 15 mm in diameter.

Although not shown in the drawing, other syringes, for example, when thesyringe having the indication 93 showing that the balloon 42 can beexpanded to 11.5 mm in diameter is used, the balloon 42 is expanded to asize corresponding to 11.5 mm in diameter. When the holes 14 and 15 areprovided on the cylinder 26, a final diameter of the balloon 42 whichcan be expanded by the capacity from the distal portion 26 a of thecylinder 26 to the position where the holes 14 and 15 are formed isshown in the indication 93.

In this embodiment, since the indication 93 is provided on the syringe92 so that a rough standard of a size of the balloon 42 which can beexpanded by the syringe 92 can be checked visually, selection of thesyringe 92 can be performed smoothly, and the time for manipulation canbe reduced.

Furthermore, since the flat portion 95 is provided in the flange storagegroove 94 c of the holding part 91 so that the rotation of the syringe92 in the stored state is prevented, the indication 93 can always beplaced on the upper surface of the syringe set. Therefore, the contentsof the indication 93 can easily be confirmed.

The effects of facilitating handling, improving reliability ofsterilization, and reducing time for manipulation by the structure ofstoring and holding the plurality of syringes 92 are the same as in theabove-described embodiments.

The invention is not limited to the above-described embodiments, and maybe widely applied.

For example, it is also possible to provide the protrusions 65 (see FIG.8) in the cylinder storage grooves 71, 72 and 73 shown in FIG. 11 tofurther reduce the contact areas with respect to the cylinders.

It is also possible to provide the flat portion 95 (see FIG. 14) in theflange storage grooves 36 a, 36 b and 36 c of the syringe holders 5 and70 in the first embodiment and the third embodiment.

While there has been shown and described what is considered to bepreferred embodiments of the invention, it will, of course, beunderstood that various modifications and changes in form or detailcould readily be made without departing from the spirit of theinvention. It is therefore intended that the invention be not limited tothe exact forms described and illustrated, but should be constructed tocover all modifications that may fall within the scope of the appendedclaims.

1. A syringe set for balloon catheter, comprising: a first syringehaving a first capacity to expand a balloon catheter to a sizecorresponding to the first capacity, the first syringe having a side airoutlet hole to define the first capacity; a second syringe having asecond capacity to expand the balloon catheter to a size correspondingthe second capacity, the second syringe having a side air outlet hole todefine the second capacity, the second capacity being larger than thefirst capacity, the diameter of the outer circumference of the secondsyringe being larger than that of the first syringe; a syringe holder atleast having a first holding part to fit to a part of the outercircumference of the first syringe for holding the first syringe inremovable manner and a second holding part to fit to a part of the outercircumference of the second syringe for holding the second syringe inremovable manner.
 2. The syringe holder for a balloon catheter accordingto claim 1, wherein the holding parts are arranged in order of sizes. 3.The syringe holder for a balloon catheter according to claim 1, whereineach holding part has a surface that restricts a longitudinal movementof a plunger of the corresponding syringe to prevent the plunger fromdropping off.
 4. The syringe holder for a balloon catheter according toclaim 1, wherein the holding parts are formed to provide an allowancewith respect to a surface contour of a corresponding syringe, arespectable inner surface of each holding part including at least oneprotrusion.
 5. The syringe holder for a balloon catheter according toclaim 18, wherein the holding parts have a non-circular cross-sectionwhich is substantially orthogonal to the direction of a length thereof.6. The syringe holder for a balloon catheter according to claim 1,wherein the holding parts are formed with a flat portion forconstraining rotation of a syringe coming into abutment with a flange ofthe syringe.
 7. The syringe holder for a balloon catheter according toclaim 1, wherein the holding parts are formed with an opening forallowing a distal portion on a side of a connecting portion forconnecting a syringe with the balloon catheter to project therefrom. 8.The syringe holder for a balloon catheter according to claim 1, whereinthe holding parts include a storage groove, the storage groove includingan opening for inserting a syringe.
 9. The syringe holder for a ballooncatheter according to claim 1, wherein the storage groove includes aprojection at an upper portion thereof for preventing a stored syringefrom dropping off.
 10. The syringe holder for a balloon catheteraccording to claim 18, wherein the syringe holder is resilient, so whena syringe is inserted therein, the opening is widened by resilientdeformation.
 11. The syringe holder for a balloon catheter according toclaim 1, wherein the storage groove comprises at least a cylinderstorage groove for storing a cylinder of the syringe, a flange storagegroove for storing the flange of the syringe, and a plunger storagegroove for storing a plunger of the syringe in communication with eachother.
 12. The syringe holder for a balloon catheter according to claim1, wherein the cylinder storage groove has a size smaller than theflange of the syringe so that the cylinder of the syringe is preventedfrom moving in an axial direction and dropping off.
 13. The syringeholder for a balloon catheter according to claim 1, wherein the plungerstorage groove is closed on one end surface so as to prevent the plungerof the syringe from coming apart from the cylinder and dropping off. 14.The syringe holder for a balloon catheter according to claim 1, whereinthe storage groove constrains rotation of the syringe in acircumferential direction.
 15. The syringe holder for a balloon catheteraccording to claim 1, in combination with at least one syringe stored ina corresponding holding part of the syringe holder, to form a syringeset for a balloon catheter.
 16. The syringe holder for a ballooncatheter according to claim 15, wherein the syringe set includes aballoon catheter.
 17. The syringe holder for a balloon according toclaim 15, wherein the syringe set is enclosed in a sterilized package.18. The syringe holder for a balloon catheter according to claim 17,wherein the syringe set is enclosed in a single sterilized package.